MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® CADD-LEGACY® PUMP; PUMP, INFUSION, PCA

Model Number 1400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Overdose (1988); Convulsion, Clonic (2222)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that the patient using this ambulatory infusion pump experienced convulsions due to over delivery of medication by the pump.The patient was treated and hospitalized for four days.No additional adverse patient effects were reported.

• Brand Name: CADD® CADD-LEGACY® PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7177624
• MDR Text Key: 96807760
• Report Number: 3012307300-2018-00044
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DUODOPA; SIFROL
• Patient Outcome(s): Hospitalization; Required Intervention